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Retrograde Intrarenal Surgery Low Risk Trial

NCT06741917 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-12-19

No results posted yet for this study

Summary

In the treatment of kidney stones and upper ureteral stones, flexible ureteroscopic lithotripsy has become the mainstream choice due to its minimally invasive nature and high safety. However, there is still no universal consensus on the use of prophylactic antibiotics before surgery. Taiwan, located in the subtropical region, is one of the areas in the world with a high incidence of urinary tract stones. Currently, there are no established guidelines for the use of prophylactic antibiotics before flexible ureteroscopic lithotripsy in Taiwan. This study aims to evaluate the differences between single-dose, different types of prophylactic antibiotics in generally healthy adult patients undergoing flexible ureteroscopic lithotripsy.

Conditions

  • Retrograde Intrarenal Surgery
  • Renal Stones

Interventions

DRUG

Levofloxacin

single dose of oral Levofloxacin (500mg/tab) before retrograde intrarenal surgery

DRUG

Cefmetazole (drug)

single dose of intravenous Cefmetazole (1000 mg)before retrograde intrarenal surgery

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06741917 on ClinicalTrials.gov